医院医学工程科技术管理规范专题三——医院医疗器械质量管理技术规范探讨

Discussion on Rule of Quality Managing Technology for Medical Apparatus & Equipment

目的:对医疗设备质量管理技术的研究是当前医院医学工程部门重点发展的技术之一,是医院长期稳定发展的重要保证。方法:从医疗设备管理技术的基本定义、原理、内涵和外延出发,阐述了医院质量控制技术的程序和总体要求,医疗设备质量控制体系建立和实施的方法,医疗器械不良事件报告制度建立的远景和近期目标。结果:指出医疗器械质量管理的法制性、系统性和医学工程行业人员所应扮演的角色及承担的责任。结论:医疗设备质量管理技术规范的制定将有效地提高医院整体质量水平。

Objective To research the quality management technique of medical device that as an important technique of medical engineering department in hospital is a guarantee of the hospital＇s development. Methods The definition, elements, signification and extension of management technique, elaborated the technique process and requirement of the quality control in hospital were introduced. Results Following an analysis of the quality control system and actualizing methods, perspective and current objective of the accident report system, legal and systemic quality management, as well as the role and responsibility of medical engineering practitioner were discussed. Conclusion The quality level of hospital will be fully improved depending on establishment of the quality management technique for medical device.